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EU agency accepts Sandoz application for pegfilgrastim biosimilar
February 11, 2016 / 6:45 AM / 2 years ago

EU agency accepts Sandoz application for pegfilgrastim biosimilar

The logo of Swiss pharmaceutical company Novartis is seen at the company's plant in Hueninge, France January 27, 2016.Arnd Wiegmann

ZURICH (Reuters) - The European Medicines Agency (EMA) has accepted an application to review Sandoz's biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulating factor, Sandoz parent Novartis said on Thursday.

Sandoz is seeking approval for the same indication as the reference product, it added in a statement.

The U.S. Food and Drug Administration in November accepted Sandoz's submission for approval of a biosimilar version of Amgen's Neulasta drug that fights infections in cancer patients.

Reporting by Michael Shields

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